ProcessDevelopmentEngineer-SyntheticandBioconjugationScale-UpTechnologies(SBST)

We are seeking a **Process Development Engineer I** to join our Synthetic and Bioconjugation Scale-up Technologies (SBST) group as a part of our Preclinical Manufacturing & Process Development (PMPD) department. In this exciting new role, you will develop manufacturing processes for the production of synthetic small-molecules used in Regeneron’s diverse range of therapeutic modalities. You would work in close collaboration with cross-functional teams performing chemical process development and optimization using the principles of Quality by Design (QbD) to deliver processes suitable for GMP production. This role also involves process scale-up and technology transfer of manufacturing related workflows to Contract Development and Manufacturing Organizations (CDMOs) to ensure timely and reliable entrance to the clinic and eventual commercialization. ## A typical day in the role of a Process Development Engineer I might include: * Working at the bench to design and develop scalable, robust and controlled GMP-ready processes for synthetic small molecules. * Collaborating with analytical groups within or outside the organization to establish supportive analytical characterization of synthetic intermediates and final products. * Discussing plans and data in multi-functional teams to evaluate processes and determine developmental goals and ensure integrated program success. * Proactively complying with lab safety and environmental safety expectations of both Regeneron and regulatory bodies such as Food and Drug Administration (FDA), Department of Transportation (DoT), etc. * Using statistical design of experiments (DOE) to optimize synthetic chemical processes including reaction parameters, purification operations, and analytical characterization. * Partnering with External Manufacturing group and other key partners at Regeneron’s IOPS organization to provide technical assessment of CDMOs intended for GMP production and successfully transferring processes with immediate, fi